NCT03728920

Brief Summary

Hypothesis We hypothesise that hip muscle strength can predict the outcome of hip arthroscopy. A relationship between strength and outcome can improve the success of the procedure and avoid unnecessary and potentially harmful surgery. Objectives The primary objective is to evaluate the relationship between hip muscle strength and outcomes of hip arthroscopy. The secondary objective is to determine a 'threshold strength' above which the operation becomes successful. If this relationship is established, it would launching a randomised control trial with targeted physiotherapy as the intervention. Background Hip arthroscopy is key-hole surgery to the hip joint which is performed for femoroacetabular impingement; a condition which describes a shape mismatch between the ball-and-socket hip joint. The number of procedures is increasing, however, studies have shown success in only half of patients undergoing the procedure. Several factors have been linked with outcomes; however, the influence of muscle strength has never been investigated. We performed a systematic review of this topic, revealing that muscles around affected hips are significantly weaker. We also developed a standardised protocol for the measurement of muscle strength. Plan Patients awaiting hip arthroscopy will undergo muscle strength testing pre- and post-operatively. There will be no deviation of treatment from their NHS care. Validated outcome measure questionnaires will be completed at five months post-operatively. Magnetic resonance imaging and electromyography tests will be performed on a subset of patients post-operatively.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 2, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

October 31, 2018

Last Update Submit

October 31, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hip Outcome Score

    Patient reported outcome measure to assess the success of hip arthroscopy

    6 months post-operatively

Interventions

Patients awaiting hip arthroscopy will undergo muscle strength testing pre- and post-operatively. There will be no deviation of treatment from their NHS care. Validated outcome measure questionnaires will be completed at five months post-operatively. Magnetic resonance imaging and electromyography tests will be performed on a subset of patients post-operatively.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Young adult patients suffering with femoroacetabular impingement, prior to the development of arthritis

You may qualify if:

  • Patients aged 18-45 years with evidence of FAI on MRI scan (the standard method of imaging of the condition in the NHS)
  • Competent to consent to study participation

You may not qualify if:

  • Established osteoarthritis with evidence of osteophytes (Tonnis grade \>2)
  • Patient with hip dysplasia (centre-edge-angle \<20 degrees)
  • Patients with full thickness cartilage (chondral) lesions
  • Previous diagnosis of mental health disorder
  • Failure to comply with Addenbrooke's hospital post-operative rehabilitation exercises tailored to hip arthroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical and Research Fellow

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 2, 2018

Study Start

January 10, 2019

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

November 2, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share